Titanium nitride-oxide coated stent: Six-month angiographic and intravascular ultrasound follow-up

JACC

ABSTRACTS

March 19,2003

follow-up,

all patients

no target

lesion revascularisatkms

in each study arm remained

expected

to stalt in September

plete 6 month follow-up Conclusions:

reported

follow-up

2002. At time of presentation,

angiographic

The FUTURE

free of any cardiac events. There were

so far. 6 month

aXaminatiOnS

we will present

the new Everolimus coated Challenge-Stent uneventful in-hospital and m-day follow-up

experience

demonstrating

Safety of

with a 100% procedural success rate and an in all patients. The 6 month follow-up data will

be presented.

Evaluation of a Tacrolimus-Eluting Coronary Stent With Nanoporous Ceramic Coating in Treatment of Native Coronary Artery Lesions: Phase I and II of the PRESENT Study

Ulrich Gerckens.

Lutz Buellesfeld.

Dieter Horstkotte.

Ralf Mueller,

Manfred

Guide Selbach. Thomas Schmidt, Eberhard Grube. Healt Center Siegburg, Germany, Heart Center Bad Oeynhausen. Bad Oeynhausen, Germany Background:

Drug eluting

Ing techniques liferative

stents (DES)has

for intetventional

(transplant

medication).

on smooth

recently

treatment

and antiinflammatory

focused

agent

emerged

of coronary

Marie-Jeanne Bernard

with proven

The antiproliferative

efficacy

safety defined

effect in coronary

and Results:

The PRESENT

as absence

of MACE.

is an antiproareas

applications

is selectively cell prolifera-

France Titanium

nitride

oxyde

(Ti-NO)

30.day

MACE

in each

group;

study, evaluat-

was scheduled

at

analysis after enrollment of 22 and 2 respectively, showed absence of in-hos-

however,

3 target

vessel

revascularisations

beyond the 30 day period in the group of DES were observed and the trial was halted (phase I). After modification of the stent design with increase in drug dosages loaded on the DES, the trial was restarted

evaluating

the bare ceramic

reduced

neointimal

proliferation

Inclusion

high dose DES group has been enrolled implantation.

At time of presentation,

the phase I and II patient population be presented. The PRESENT

without

complete

any adverse procedural

as well as B-month

trial demonstrates

of the first stem version.

cacy of this concept

Phase

in treatment

and 30 day follow-up

angiographic

safety and feasibility

Background:

Stent

will clarify the effi-

lesions.

infarction.

Pache, Josef 1. Med. Klinik

integrating

an active

The commercially

(9Opm) with a phosphorylcholine

coating

by the SOPHOS

trial. The standard

of biomolecules

(batimastat.

available

drug

for local

BiodivYsio

(PC) with favorable

PC coating

angiopeptin

delivery

is currently

stent is a thin-strut long-term

has been modified

and others).

stent

results as shown

to allow local delivery

Goal of the present

study was to

evaluate the efficacy of the BiodivYsiostent with this Matrix HI polymer coating (MBIO) without an active drug, by comparison with the Guidant RX MultiLink (ML) which was the stent with the lowest restenosis Methods & Results: syndrome in 36.7%) Baseline

rate in both ISAR-STEREO

Patients with symptomatic were randomly asslgned

clinical

and

angiographic

coronary to either

trials. artery disease (acute coronary the MBIO (n=142) or the ML

characteristics

did not differ

significantly

between the 2 groups; vessel size was 3.OOi.54 (MBIO) vs. 3.06+.50mm (ML), lesion length 13.2+6.9 vs. 13.1&.9mm. Number of stents implanted (1.3k.9 vs. 1.3+.6), balloon/vessel

ratio (1.16+.12

vs. 1.16~.13),

and final

%-diameter

stenosis

(5.629.7

vs.

5.OA6.9) did not differ significantly. Repeat angiography (performed in 60% of eligible pts.) revealed restenosis (~50% diameter stenosis) in 37.3% with MBIO and 17.3% with ML (pc.OOl),

late loss was 1.17*.75

revascularization Conclusions:

suggest

accounted

different

In this randomized

mer coating (without standard PC-coated data

vs 0.98+.63mm

was done in 22.5 vs. 13.4% (pz.04).

arction was not signiftcantly

steel

mm in length in a native coronary

artery

Clinical

follow-up

was performed

at one month

performed

at six months.

QCA

133 patients

were included

in the study. 40 pts were selected

a negative

effect

IVUS

analysis

folwere

for post implantation

and

six months IVUS analysis. Mean age was 62.4 * 11.4 y. Prior history of diabetes was 19%. CABG :I%, PCI: 5%. MI 19%. Clinical presentation was unstable angina 43%,

:

23%. post Ml

: 17%,

silent ischemia:

17%. ACC/AHA

classification

lesion

was A:29%, B: 71%. Reference diameter with QCA analysis was 3.21* 0.36mm. MLD pre and post stent were I.142 0.32 and 2.99+ 0.35mm. Post implantation IVUS reference diameter

was 4.32+/- 0.45mm,

reference

area was 14.61+/-2.57mm2,

stent symetry

was

0.9+/-0.03 and stent lumen cross section area was 9.01+/-2.05mm2. Success rate implantahon was 100%. In hospital events was one death due to per-procedure aortic dissection,

one regressive

stroke and two groin haematomas.

thrombosis, no TLR and no Ml was observed. In conclusion immediate and one month follow-up angiographic

and IVUS follow-up

is ongoing,

At one month no subacute

results are very promising.

complete

Six months

results will be communicated

dur-

ing the presentation.

POSTER

SESSION

1007

Intravascular Ultrasound Cardiovascular Disease

and

Sunday, March 30, 2003, 9:00 a.m.-l 1:OO a.m. McCormick Place, Hall A Presentation Hour: 9:00 a.m.-10:OO a.m. of Renal Artery Stenosis in 2,111 Patients Undergoing Coronary Angiography: A Model of Predictive Risk of Renal Artery Stenosis

73

Grayson

Incidence

G. Geary,David

J. Tanous

David L. Ross, Westmead

Hospital,

Sydney,

Background: Renal artery stenosis (RAS) is an important cause of hypertension and ischemic renal disease and should be identified in patients (pts) where possible. Data on the predictive

risk of RAS at the time of coronary

angiography

subgroup

of pts. Methods:

A total of 2111 consecutive

pts were screened

with CAD. Independent

the BiodivYsiostent

with Matrix

of the Matrix

and interpreting

HI polymer

coating.

This

needs

for RAS with a

risk factors for RAS in pts with CAD were age (Odds

ratio (OR)

l.O5/year, p
(OR 1.56, p=O.Ol).

A model was developed

utlliz-

ing these risk factors which enables the prediction of RAS in different patient profiles. An example is shown for males aged 60 with hypertension and CAD. Conclusions: RAS was rare in pts without

CAD. In pts with CAD, there was a relatively

high Incidence

of unsus-

pected RAS (13%). In pts with CAD and RAS there was a high incidence of other vascular disease. The incidence of RAS in pts with CAD can be predicted using the model developed

and may aid in determining

which pts should

be screened.

inf-

(4.9 vs. 4.9%).

comparison,

patient profiles

contrast injection in the descending aorta after the ventriculogram. Multiple risk factors were assessed. Results: RAS was present in 1% of pts without CAD and in 13% of pts

(p=.O4). After 1 year, target vessel the rate of death or myocardial

for different

is lacking. Our aim was to determine the incidence of RAS in a large group of pts undergoing coronary angiography and to develop a model to determine the risk of RAS for any

HI poly-

active drug) has less favorable results. As the restenosis rate for the BiodivYsio was much lower in the SOPHOS trial (17.7%). these

for when designing

and angiographic

and

Australia

Intensely investigated to prevent restenosis after coronary stent placement. Stem design, surface, and as shown in the ISAR-STEREO l&2 trials, strut thickness have a significant on restenosis.

stainless

systematically

1007-l

Germany

coating

steel stent in pigs. The aim of our

low-up was centralized.

of a new ceramic

Helmut SchOhler$ Adnan Kastrati, Julinda Mehilli, J&g Hausleiter, Jiirgen Dirschinger, Albert Schbmig. Deutsches Herzzentrum. Munich, Germany, rechts der Isar. Munich,

to stainless

the feasibility and safety of a Ti-NO France) in humans.

data of

and IVUS data will

Evaluation of the BiodivYsio Stent With Matrix HI Coating Designed for Local Drug Delivery in Coronary Arteries: A Randomized Trial

1006-185

biocompatibility

cardiac events after DES

II with high dose Tacrolimus

of coronary

compared

has an excellent

reaction as well as an absent complex Ti-NO coated stent has significantly

coated stent and the modi-

coated coronary stent with and without elution of Tacrolimus. The need of target vessel revascularisations in the low dose group (phase I) might suggest an inappropriate drug

(n=l42).

inert

criteria were a single lesion less than15

fied high dose drug eluting stent in 30 patients each (phase II). To date, 24 patients in the

impact

is biologically

study was to prospectively evaluate coated stem (Helistent @, Hexacath,

stable angina:

in treatment of native endpoint was 30-day

and IVUS follow-up

Gilles Grollier,

Le Plessis Robinson,

cardial

of endothelial

Study is a prospective

Angiographic

6 months after index procedure. The interim patients with DES and contol stent implantation,

loading

Meyer Elbaz, Martial Hamon,

C.C. Marie Lannelongue.

Siegburg,

in other therapeutical

ing the ceramic coated coronary stent with and without Tacrolimus coronary de-nova lesions with 30 patients in each arm. Primary

Conclusion:

Alibelli,

Lancelin,

Staberock,

as one of the most promis-

lesions. Tacrolimus

muscle cell activities rathsr than inhibition

conducted.Methods

and

Caussin

Commeau,

with a reference diameter between 3.0 and 4.0 mm eligible for PCI. Exclusion criteria were high-grade calcifications, ostial or bifurcation lesion, less than 72 hours acute myo-

tion. To evaluate both safety and feasibility of a Tacrolimus eluting stent, which utilizes a nanoporous aluminium oxide ceramic as drug carrier, the PRESENT study have been

pital

Philippe

exemplified by the lack of a redox and hydrolysis metal ion-organic molecule binding formation.

1006-184

7A

Cardiology

the comChristophe

a pioneer

& Interventional

Titanium Nitride-Oxide Coated Stent: Six-Month Angiographic and Intravascular Ultrasound Follow-Up

86

are

and IVUS data.

trial represents

1006-l

- Angiography

to be

studies with this stem coating.

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